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ISO 9001:2015 Process Library

 

 

 

 

 

 


Processes    Management    Resources    Improvement    Business    Operational Quality Management

 

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1. PDCA Cycle

 

Positioning of the process groups within the ISO 9001:2015 PDCA cycle referring to the chapters of the standard.

 

 

2. Processes

 

 

2.1. Management Processes

 

2.1.1. Quality Policy and Organization

 

Interfaces Quality Policy and Organization

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Definition of Quality Policy

 

Definition, formulation and documentation of the quality policy

 

Operationalization of Quality Policy

 

Operationalization and execution of implementation activities for the quality policy

 

 

 

2.1.2.Development and Maintenance of QM System

 

Interfaces Development and Maintenance of QM System

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Definition of Medium Term Maintenance and Development Activities

 

Definition of potential medium term activities for the future maintenance and development of the quality management in the company

 

Management of Improvement Proposals

 

Intaking of, evaluation of and relevant reaction to improvement proposals including feedback to the proposer

 

 

 

2.1.3. Evaluation and Optimization of QM System

 

Interfaces Evaluation and Optimization of QM System

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Maturity Evaluation

 

Diagnosis and evaluation of the maturity of the quality management system

 

Management Review

 

Definition of a structured portfolio of future developments of the quality management in the company based upon a complete review of the effectivity of the quality management system

 

Short Term Optimization Activities   Definition of potential short term optimization activities for the quality management in the company and as far as possible immediate implementation

 

 

2.1.4. Document and Record Control

 

Interfaces Document and Record Control

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Organization of Document and Record Control

 

Organization of processes and procedures for the life cycle management of documents and records needed to be controlled:

  • creation

  • checking

  • approval

  • distribution

  • cancellation (documents)

  • archiving period (records)

Operational Document and Record Control

 

Operational life cycle management of documents and records needed to be controlled:

  • creation

  • checking

  • approval

  • distribution

  • cancellation (documents)

  • archiving period (records)

 

 

2.1.5. Quality Documentation and Reporting

 

Interfaces Quality Documentation and Reporting

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Maintenance of Documentation of the QM - System

 

Permanent actualization and further development of the documentation of the quality management system

 

Ensuring the Quality Documentation

 

Ensuring of operational documentation of quality operations

 

Actualization of Quality System Procedures

 

Provision of relevant reporting for the quality management

 

Quality Reporting

 

Creation of relevant reporting for the quality management

 

 

2.1.6. Process Management

 

Interfaces Process Management

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Process Management Review

 

Continual validation and improvement of the procedures and methodologies of the company wide process management

 

Process Coordination

 

Coordination of life cycles of company wide processes and ensuring friction free integration

 

Process Controlling

 

Assessment of company wide processes by analysis of their performance indicators and deduction of improvement potentials

 

Implementation of Business Processes

 

Design and implementation of new respective modified business processes according to the business requirements based upon the formal requirements of process management

 

Process Review  

Checking the company wide processes for problem areas on regular basis and introduction of necessary activities thereof

 

End of Life for Business Processes   Controlled shut down of usage of defined business processes

 

 

2.1.7. Management of Conformity Risks

 

Interfaces Management of Conformity Risks

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Risk Analysis from Conformity Perspective

 

Analysis of criticality of products and services from conformity perspective

 

Risk Prevention Activities

 

Activities against detected conformity risks including process and responsibilities thereto

 

Risk Monitoring and Reporting

 

Management of risk avoiding activities (surveillance, triggering of corrective actions) and reporting thereto

 

 

2.1.8. Knowledge Management

 

Interfaces Knowledge Management

 

Integration with other ISO 9001 process groups and main information flows thereto

 

Gathering Know How Relevant Documents

 

Structured collection and archiving of the knowledge of the (quality-)organization

 

Knowledge Review

 

Review of the actuality of the knowledge management database

 

2.2. Resource Processes

 

2.2.1. Personnel Qualification

 

Interfaces Personnel Qualification

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Actualization of Qualification Requirements

 

Review of requirements to personnel qualification and triggering of adequate activities to ensure sufficient qualification in case of changed requirements

 

Planning of Activities for Personnel Qualification

 

Planning of adequate activities to ensure sufficient qualification according to the quality requirements

 

Control of Activities for Personnel Qualification

 

Control of execution and effectivity of adequate activities to ensure sufficient qualification according to the quality requirements

 

 

2.2.2. Infrastructure Qualification

 

Interfaces Infrastructure Qualification

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Actualization of Infrastructure Requirements

 

Review of requirements to infrastructure and triggering of adequate activities to ensure sufficient infrastructure in case of changed requirements

 

Planning of Activities for Infrastructure Qualification

 

Planning of adequate activities to ensure sufficient infrastructure according to the quality requirements

 

Control of Activities for Infrastructure Qualification

 

Control of execution and effectivity of adequate activities to ensure sufficient infrastructure according to the quality requirements

 

 

2.2.3. Budget for Quality Management

 

Interfaces Budget for Quality Management

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Budgeting for Quality Management

 

Planning of sufficient financial resources to fulfill the quality requirements and targets

 

Controlling for Quality Management

 

Economic control of utilization of financial resources for the quality management

 

 

2.3. Improvement Processes

 

2.3.1. Supplier Audits

 

Interfaces Supplier Audits

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Supplier Audits Planning

 

Periodical and event triggered planning of supplier audits

 

Supplier Audits Execution

 

Execution of scheduled periodical respective event triggered supplier audits according to the supplier audit planning

 

 

2.3.2. Internal Audits

 

Interfaces Internal Audits

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Organization of Self Assessments

 

Organization of the internal evaluation of the quality management system from inside the organization

 

Self Assessment

 

Planned and event triggered internal evaluation of the quality management system from inside the organization

 

Audit Planning

 

Periodic and event triggered planning of internal audits

 

Audit Execution

 

Execution of scheduled periodical respective event triggered internal audits according to the internal audit planning

 

 

2.3.3. Customer Satisfaction

 

Interfaces Customer Satisfaction

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Customer Satisfaction Surveys

 

Proactive collection of information about the satisfaction of the consumers with the supplies of the company and introduction of necessary activities thereof

 

Customer Feedback Management

 

Management of feedback (complaints and commendation) from customers and introduction of necessary activities thereof

 

Monitoring of Customer Complaints

 

Monitoring of open customer complaints to enable necessary counter activities

 

 

2.3.4. Control of Defective Products and Services

 

Interfaces Control of Defective Products and Services

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Organization of Control of Defective Products and Services

 

Setup of processes, definition of responsibilities and documentation standards for the control of defective products and services

 

Control of Defective Products

 

Ensuring that defective products are
  • identified and indicated
  • removed from the further production respective service process
  • subject to a special deviation permit in case of further usage respective rework
  • accordingly documented in all steps of their further treatment
  • analyzed for defect causes
  • undergoing corrective actions with defined responsibilities to avoid recurrence of the detected defects causally

Control of Defective Services

 

Ensuring that defective services are
  • identified and documented
  • removed from the further production respective service process
  • subject to a special deviation permit in case of further usage respective rework
  • accordingly documented in all steps of their further treatment
  • analyzed for defect causes
  • undergoing corrective actions with defined responsibilities to avoid recurrence of the detected defects causally

 

 

2.3.5. Activities for the QM System

 

Interfaces Activities for the QM System

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Implementation Planning of Activities for the QM System

 

 

Implementation planning for all registered activities for the quality management system regarding their interdependencies

 

Implementation Management of Activities for the QM System

 

Management of implementation and monitoring of all registered and planned actions for the quality management system

 

Corrective and Preventive Actions

 

Definition and triggering the execution of corrective actions for detected defects respective preventive actions

 

Reporting for Corrective and Preventive Actions

 

Reporting and knowledge management for corrective and preventive actions

 

 

2.4. Business Processes

 

2.4.1. Marketing and Sales

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.2. Planning

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.3. Production and Service Delivery

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.4. Dispatch and Handover

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.5. Customer Service

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.6. Product and Service Development

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.7. Procurement

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.8. Logistics

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.9. Operational Quality Assurance

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.10. Finance and Controlling

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.11. IT

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.12. Facility Management and Maintenance

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

2.4.13. Human Resources

 

Customer specific process, hence documentation of the inputs from and the outputs to the quality management (interface)

 

 

1.5. Operational Quality Management

 

2.5.1. Management of Test Equipment

 

Interfaces Management of Test Equipment

 

Integration to other ISO 9001 - process groups and main information flows thereto

 

Organization of Management of Test Equipment

 

Organization of the lifecycle management of test equipment

Operational Management of Test Equipment   Operational lifecycle management of test equipment

 

 

2. ISO 9001:2015 Roles

 

Via the Signavio - Dictionary the responsible roles for all processes and process steps including detailed descriptions are documented.

 

 

3. ISO 9001:2015 Documents

 

Via the Signavio - Dictionary all relevant process documents for all processes including detailed descriptions are documented.

 

 

4. Templates

 

The templates are linked to glossary entries and with process steps also (if appropriate).

 

5. Checklists

 

The checklists are linked to glossary entries and with process steps also (if appropriate).

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_ © 2006 - 2018 Dipl.-Ing. Walter Abel Management Consulting Last update 2018-05-21 _